Clinical research participation among adolescent and young adults at an NCI-designated Comprehensive Cancer Center and affiliated pediatric hospital

Abstract

Purpose Minimal clinical trial participation among adolescents and young adults (AYAs) with cancer limits scientific progress and ultimately their clinical care and outcomes. These analyses examine the current state of AYA clinical research participation at a Midwestern comprehensive cancer center and affiliated pediatric hospital to advise program development and increase availability of trials and AYA participation. Enrollment is examined across all diagnoses, the entire AYA age spectrum (15–39), and both cancer therapeutic and supportive care protocols. Methods This study was a retrospective review of electronic medical records via existing databases and registries for all AYAs. Data were collected for AYAs seen by an oncologist at the adult outpatient cancer center or at the pediatric hospital between the years 2010 and 2014. Descriptive statistics and logistic regression analyses were conducted to characterize this sample. Results In the pediatric setting, 42.3% of AYAs were enrolled in a study compared to 11.2% in the adult setting. Regression analyses in the pediatric setting revealed that AYAs with private insurance or Caucasian race were more likely to participate. Within the adult setting, ethnicity, race, insurance, and diagnosis were associated with study participation; 54.8% of study enrollments were for cancer therapeutic and 43.4% for supportive care studies. Conclusions These results are comparable to previously published data and support the need for new local and national AYA initiatives to increase the availability of and enrollment in therapeutic clinical trials. The same is true for supportive care studies which play a crucial role in improving quality of life.

A prospective comparison of cancer clinical trial availability and enrollment among adolescents/young adults treated at an adult cancer hospital or affiliated children’s hospital

“…Although CCTs existed nationally for more than half of our AYAs at both sites, CCTs were available for only one third as many AYAs at the adult cancer hospital. Although the overall low CCT enrollment of about 10% at both sites was not unexpected and is consistent with previous reports, 1,8,13,17 our findings of national-level similarity in CCT existence, but site-level disparity in CCT availability, are novel. They are significant because they demonstrate the need to account for treatment setting when considering solutions for the difficult problem of low CCT enrollment of AYAs.…”

Increased clinical trial enrollment among adolescent and young adult cancer patients between 2006 and 2012–2013 in the United States

“…19 Sanford et al examined AYA enrollment onto clinical trials from 2010 to 2014 in affiliated pediatric and adult NCI-designated cancer centers, finding 11% of AYAs were enrolled in the adult setting while 42% were enrolled in the pediatric setting. 18 While our population-based study demonstrated higher overall clinical trial enrollment, as well as improvements over time, in the cancer types studied, the persistent issue of lower overall clinical trial enrollment relative to the pediatric populations remains. The relatively lower proportional enrollment of AYAs relative to other age groups was recently demonstrated in a study of clinical trial enrollment within the NCI’s CCOP.…”

“…5,11,13 Our findings are comparable to recently published studies of clinical trial enrollment among AYAs in single or affiliated institutions. 18 In a single-institution study, Collins et al found 6% of AYAs were enrolled on clinical trials from 2008-2012. 19 Sanford et al examined AYA enrollment onto clinical trials from 2010 to 2014 in affiliated pediatric and adult NCI-designated cancer centers, finding 11% of AYAs were enrolled in the adult setting while 42% were enrolled in the pediatric setting.…”

Adolescent and young adult oncology patients in France: Heterogeneity in pathways of care

“…Considering the same period, the enrollment onto therapeutic clinical trials from this study was comparable to that in other studies; in the United States, from 2009 to 2013, 21 the proportion of AYA enrollments was 29% in therapeutic studies and in the United Kingdom, in 2010, 37% of 15‐ to 19‐year‐olds and 18% of those 20 to 24 years of age were entered onto clinical trials. However, enrollment rates varied by age, cancer types, and pathway of care, with higher rates of inclusion in adolescents versus young adults and in pediatric versus adult settings . When trials are available, access might vary according to centers; AYAs seen at a children's hospital are significantly more likely to enroll compared to AYAs seen at any of the primarily adult institutions .…”